Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
895 participants
OBSERVATIONAL
2016-10-26
2020-02-28
Brief Summary
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Detailed Description
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Health-related quality of life (HRQOL) is a very important outcome that advanced heart failure patients care about when making health care decisions, including when considering surgical treatment options, such as heart transplantation and mechanical circulatory support.
Currently available HRQOL questionnaires do not assess the unique burdens of MCS, such as changing power sources and driveline exit site dressings; safety precautions (e.g., no immersion in water, need for an MCS-trained caregiver); troubleshooting VAD alarms; and MCS-specific complications, often associated with frequent hospitalizations. Since these questionnaires do not focus on issues of concern to MCS patients, they lack sensitivity and precision to measure the potentially wide-ranging impact of MCS on HRQOL.
Guided by the investigators empirically supported MCS A-QOL conceptual model, the investigators will use state-of-the-science psychometric measurement methods to create "item banks" (sets of items that comprise carefully calibrated questions which define and quantify a common theme) from the investigators existing MCS A-QOL item pools (library of relevant items). Using calibrated item banks, the investigators will develop computer adaptive tests (CATs) and fixed-length short forms to reduce respondent burden and enhance measurement precision. The investigators will assess reliability, validity, responsiveness to change, and clinically important differences of MCS A-QOL measures.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Group 1: Longitudinal assessment
Assessments will be performed pre-MCS, 3 months post-MCS and 6 months post-MCS. Participants in this group must be scheduled for MCS implant.
No interventions assigned to this group
Group 2: Cross-sectional assessment
A one-time assessment will be performed on participants who are post-MCS implant (between 3 months and 10 years post-implant). Participants in this group must already have an MCS device in place.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. The continuous flow MCS device implant strategy can be a bridge to transplant, destination therapy, or bridge to recovery
3. Age \>= 19 years and able to speak and understand English
4. Sufficient cognitive ability to provide self-report data on a computer touchscreen/standard computer and/or on paper-based forms with minimal assistance.
5. Willing to participate and able to give written informed consent
1. Patient with a continuous flow MCS device left (L)VAD who is more than 3 months post-implant at the following intervals: 3, 6, 12, 18, 24, 30, 36, 42, 48 months and every 6 months thereafter. Note: patients can have had prior MCS devices.
2. The continuous flow MCS device, implant strategy can be a bridge to transplant, destination therapy, or bridge to recovery
3. Age \>= 19 years and able to speak and understand English
4. Sufficient cognitive ability to provide self-report data on a computer touchscreen/standard computer and/or on paper-based forms with minimal assistance
5. Willing to participate and able to give written informed consent
Exclusion Criteria
1\. Has a bi-VAD, right (R)VAD, or total artificial heart
19 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Northwestern University
OTHER
Responsible Party
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Kathleen Grady
Professor of Surgery and Medicine, Feinberg School of Medicine at Northwestern University
Principal Investigators
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Kathleen L Grady, RN, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Elizabeth A Hahn, MA
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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University of California, San Diego
La Jolla, California, United States
University of California
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Colorado
Denver, Colorado, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
St. Vincent Hospital
Indianapolis, Indiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Integris Health
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Hahn EA, Allen LA, Cella D, Beiser DG, Denfeld QE, Kirklin J, Lindenfeld J, McIlvennan CK, Ruo B, Teuteberg J, Kiernan M, Klein L, Lee CS, Murks C, Rich J, Stehlik J, Walsh MN, Bedjeti K, Grady KL. Responsiveness validity for measures of adjustment to life with a left ventricular assist device: Findings from the MCS A-QOL study. JHLT Open. 2025 Apr 22;9:100269. doi: 10.1016/j.jhlto.2025.100269. eCollection 2025 Aug.
Grady KL, Kallen MA, Beiser DG, Lindenfeld J, Teuteberg J, Allen LA, McIlvennan CK, Rich J, Yancy C, Lee CS, Denfeld QE, Kiernan M, Walsh MN, Adler E, Ruo B, Stehlik J, Kirklin JK, Bedjeti K, Cella D, Hahn EA. Novel measures to assess ventricular assist device patient-reported outcomes: Findings from the MCS A-QOL study. J Heart Lung Transplant. 2024 Jan;43(1):36-50. doi: 10.1016/j.healun.2023.08.007. Epub 2023 Aug 15.
Hahn EA, Walsh MN, Allen LA, Lee CS, Denfeld QE, Teuteberg JJ, Beiser DG, McIlvennan CK, Lindenfeld J, Klein L, Adler ED, Stehlik J, Ruo B, Bedjeti K, Cummings PD, Vela AM, Grady KL. Validity of Patient-Reported Outcomes Measurement Information System Physical, Mental, and Social Health Measures After Left Ventricular Assist Device Implantation and Implications for Patient Care. Circ Cardiovasc Qual Outcomes. 2023 Feb;16(2):e008690. doi: 10.1161/CIRCOUTCOMES.121.008690. Epub 2023 Feb 8.
Carroll AJ, Hahn EA, Grady KL. Research engagement and experiences of patients pre- and post-implant of a left ventricular assist device from the mechanical circulatory support measures of adjustment and quality of life (MCS A-QOL) study. Qual Life Res. 2022 Aug;31(8):2457-2470. doi: 10.1007/s11136-022-03111-4. Epub 2022 Mar 8.
Other Identifiers
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STU00201984
Identifier Type: -
Identifier Source: org_study_id
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